This invention relates broadly to the art of balloon catheters, and more particularly to the art of miniaturized balloon catheters generally for use in blood vessels and the like.
A significant publication disclosing prior art developments in the area of this invention is Serbinenko, Balloon Catheterization and Occlusion of Major Cerebral Vessels, Journal of Neurosurgery, Volume 41, August 1975, pages 125-145. This article describes the work of Dr. Serbinenko with miniaturized balloon catheters. Dr. Serbinenko has employed balloon catheters to occlude vessels in cardiovascular surgery as well as for other purposes, and his article is incorporated by reference here.
Dr. Serbinenko employs a latex balloon that is held onto a cannula by means of an elastic string for achieving permanent occlusion of vessels. The balloon is inserted into a vessel and allowed to move to a proper position by fluid circulation within the vessel. The balloon is then inflated by means of a solidifying filler until it is fixed against the walls of the vessel. After the solidifying filler has solidified the cannula is pulled from the balloon and the balloon is left in the vessel.
A difficulty with Dr. Serbinenko's arrangement is that the balloon sometimes comes off of the cannula prematurely because the elastic string does not tightly hold the balloon to the cannula. Still another difficulty with Dr. Serbinenko's arrangement is that the solidifying filler is somewhat difficult and awkward to work with. Thus, it is an object of this invention to provide a miniaturized balloon catheter which can be used for permanent occlusion of a vessel but which is not prematurely detached from the cannula and which can be inflated by a nonsolidifying fluid.
Dr. Serbinenko has also employed a miniaturized balloon catheter to achieve perfusion. That is, Dr. Serbinenko has made a small pin-hole in his latex balloon from which a dye or the like is discharged from the balloon into the vessel. However, in Dr. Serbinenko's arrangement, the fluid to be perfused passes through the pin-hole as soon as the fluid enters the balloon. It is sometimes desirable that the fluid not pass through the hole until the balloon has accomplished occlusion of the vessel. Thus, it is another object of this invention to provide a miniaturized balloon catheter which does not initiate perfusion of fluid until the balloon has achieved occlusion of the vessel.
It is a further object of this invention to provide a miniaturized balloon catheter, and a method for using the miniaturized balloon catheter which is efficient in operation, and relatively easy and inexpensive to manufacture.